A new era for COPD
COPD is set to lose its traditional status as a Cinderella disease following its inclusion in the quality framework and the publication of NICE guidelines – Rachel Booker says controversy over the new advice must not distract GPs
and the publication of NICE guidelines – Rachel Booker
says controversy over the new advice must not distract GPs
Chronic obstructive pulmonary disease
kills 30,000 people prematurely every year1 in England and Wales and consumes a large proportion of NHS resources2. In recent years there has been a welcome upsurge of interest in this 'Cinderella' disease with the development of new therapies and new approaches to management. Far from being an intractable problem there is a lot that can be done to alleviate symptoms and improve patients' quality of life.
The recent publication of evidence-based management guidelines by NICE3, together with the inclusion of COPD in the quality and outcomes framework4, will provide renewed impetus for GPs to improve care. Practices can earn up to 45 quality points for COPD – worth £3,375 to an average three-partner practice in 2004/5.
The NICE guidelines identify seven key priorities, several of which are directly applicable to primary care management and in agreement with the quality framework. But there are also some areas of conflict and controversy that could lead to confusion.
COPD is under-diagnosed. Its slowly progressive, insidious nature means many patients have lost half their respiratory reserve before they present5. Recurrent 'winter bronchitis' may be treated with repeated courses of antibiotics and chronic cough and sputum may be dismissed by patient and health professional alike as a 'normal' consequence of smoking rather than an early warning sign of COPD6. Diagnostic spirometry may not have been considered.
The symptoms of COPD are similar to asthma. A reappraisal of the practice asthma register is worthwhile – review the diagnosis in patients whose history and presentation is more compatible with COPD. This will be initially time-consuming but is likely to pay dividends in future quality framework earnings.
Both the Q&O framework and the NICE guidelines place a justified emphasis on spirometry for diagnosis of COPD – peak expiratory flow is insufficiently sensitive8. But this has resource implications. An adequate spirometer will cost over £1,000. The personnel performing the test must be appropriately trained and need to practise their skills regularly to maintain them. Someone in the practice must also be competent in interpreting results.
Primary care spirometry services need adequate quality control systems. Alternative approaches include open access to lung function at the hospital, sharing spirometry services between several small practices, a GPwSI providing services within a PCT or PCT-organised services.
Clash of views on reversibility testing
Reversibility testing is an area of conflict between NICE and the quality framework. The evidence3 suggests reversibility testing in COPD is misleading and unreliable because:
lRepeated FEV1 measurements show spontaneous fluctuation.
lReversibility testing on different occasions in the same individual can be inconsistent and not reproducible.
lPrevious definitions of a 'positive' result were not evidence-based. Over-reliance on a single reversibility test for diagnosis may therefore be unreliable, unless the increase in FEV1 is greater than 400ml – when a diagnosis of COPD is unlikely.
lReversibility tests do not predict response to long-term therapy.
On the basis of this evidence, NICE no longer recommends routine diagnostic reversibility testing, stating that in most cases a diagnosis of COPD can be made on the basis of the history, spirometry and response to therapy. The role of reversibility testing, with bronchodilators and/or oral corticosteroids, is to differentiate between asthma and COPD in cases where the history is not clear.
But the Q&O framework appears to go against the current evidence base in awarding up to five points for diagnosing COPD with spirometry and reversibility testing.
Finding a way out of the quandary
GPs can take two possible approaches to resolving this conflict.
lPerform reversibility tests in all suspected COPD patients. Where the history suggests COPD, an improvement of less than 400ml FEV1 will support the diagnosis.
lProvisionally diagnose COPD on the basis of history and spirometry. Give a therapeutic trial of regular bronchodilators and review after four to six weeks. Assess response in terms of symptomatic improvement and repeat the spirometry. COPD is unlikely if the FEV1 and the FEV1/FVC have returned to normal, or there is a large improvement in the FEV1. Spirometry following a therapeutic trial can be recorded as a 'reversibility test'. This approach has the advantage of ensuring GPs stay in line with the NICE guidance and don't miss asthma – but still qualify for their quality payment.
Smoking cessation is the only intervention that significantly slows the rate of COPD progression. Patients must be supported and encouraged at all stages and at every opportunity. Nicotine replacement and bupropion are effective8.
The NICE guidelines highlight advances in therapy for COPD.
Bronchodilators – both ß2-agonists and anticholinergics – are the cornerstone of therapy.
They reduce symptoms and improve functional ability even though they have little or no effect on the FEV1. Long-acting ß2-agonists and anticholinergics have recently become available. They are effective in reducing symptoms and they have also been shown to reduce exacerbation rates and improve health status. NICE recommends they are introduced when regular short-acting agents fail to adequately control symptoms.
The role of inhaled corticosteroids in COPD is now better understood. Moderate to high-dose inhaled corticosteroids reduce exacerbation
rates and associated health status decline in patients with moderate to severe disease (FEV1 50 per cent predicted or less).
They are not effective in patients with less severe disease. NICE suggests they are used in moderate to severe COPD where the patient also experiences two or more exacerbations a year. Inhaled corticosteroids are generally added to long-acting bronchodilators. Combination inhalers of long-acting ß2-agonists and inhaled corticosteroids (Symbicort 400 and Seretide 500 accuhaler) are licensed for use in COPD and are effective in reducing exacerbation rates and improving symptoms.
Mucolytics have been shown to be beneficial9 and were removed from the NHS 'blacklist' in 2003. The NICE guidelines suggest a trial of therapy when chronic cough and sputum are troublesome. Mucolytics should be continued if the patient reports symptomatic benefit.
Pulmonary rehabilitation is highly effective at improving disability and functional ability and can result in dramatic improvements in health status3. Despite ample evidence of its effectiveness in both community and hospital settings, service provision is poor. NICE said pulmonary rehabilitation should be offered to all COPD patients who consider themselves to be functionally disabled by their disease.
It is hoped this recommendation will provide the impetus to improve service provision.
There is good evidence that annual influenza vaccination is effective in reducing mortality and hospital admissions9. It should be actively encouraged. Evidence for the effectiveness of pneumococcal vaccine remains scant, but it is still recommended.
NICE makes recommendations for the regular review of COPD patients and the quality framework awards points for monitoring FEV1 so patients who experience rapidly declining lung function are referred promptly, and for checking inhaler technique.
The use of pulse oximeters is recommended by NICE, although they are not yet in widespread use in primary care.
They are not expensive and will enable the early detection of chronic hypoxaemia, resulting in earlier referral for long-term oxygen therapy with improved outcomes for patients.
For the first time the importance of COPD in primary care has been recognised and practices that deliver good care will be financially rewarded. The quality framework is still in its infancy and will be subject to refinement and review. The inclusion of patient outcome measures seems likely to follow in time.
For now, despite the controversy and confusion sparked by differing advice on reversibility testing, both NICE and GMS should be welcomed. Together they could be the 'fairy godmother' that begins to take this 'Cinderella' disease to the ball.
Rachel Booker is COPD module leader at the National Respiratory Training Centre and a member of the British Thoracic Society COPD consortium
•NICE guidelines: www.nice.org.uk/Docref.asp?d=106421
•British Thoracic Society COPD consortium: www.brit-thoracic.org.uk/copd
•National Respiratory Training Centre (one-day short courses on COPD; spirometry and achieving Q and O targets for respiratory disease: www.nrtc.org.uk
1 Office for National Statistics. Mortality statistics: Cause 1999. DH2 (No 26). 2000. London. HMSO
2 Britton M. The burden of COPD in the UK: results from the Confronting COPD Survey. Respiratory Medicine 2003; 97 Suppl C: S71-S79
3 National Collaborating Centre for Chronic Conditions. National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax 2004; 59 Suppl 1: 1-232
4 New GMS Contract 2003 – Investing in General Practice – Supporting documentation. London: BMA and NHS Confederation, 2003
5 Fletcher C, Peto R. The natural history of chronic airflow obstruction.
BMJ 1977; 1(6077): 1645-8
6 van Schayck C et al. Detecting patients at high risk of developing chronic obstructive pulmonary disease in general practice: a cross-sectional case-finding study.
BMJ 2002; 324: 1370-4
7 Nolan D et al. FEV1 and PEF in COPD management. Thorax 1999; 54: 468-9
8 National Institute for Clinical Excellence. Guidance on the use of nicotine replacement therapy and bupropion for smoking cessation. Technology Appraisal Guidance no. 39. London. NICE
9 Poole PJ et al. Influenza vaccine for patients with chronic obstructive pulmonary disease. (Cochrane Review). The Cochrane Library. Oxford: Update software 2003'. Issue 3
Quality pay targets are out of date
The inclusion of COPD in the quality and outcomes framework and the recent publication of evidence-based NICE guidelines should help change attitudes about the importance of diagnosis, symptom control and prevention of acute exacerbations, writes Dr David Bellamy (right).
But the situation is not helped by the confusion caused by conflicts between the framework and the more evidence-based recommendations of NICE. The quality framework was drawn up at least a year before the NICE advice and was produced by at most two academic GPs. They sensibly suggested spirometry with reversibility testing be used to confirm every diagnosis of COPD and to differentiate it from asthma.
NICE, in conjunction with other international respiratory groups, has looked at studies showing the variability of reversibility tests within individuals over time and the lack of evidence base for the previous figures used for defining a reversibility. This led it to conclude it is possible to make a diagnosis in many cases on clinical history plus airflow obstruction on spirometry – reserving reversibility testing for cases where doubt remains.
NICE has made representations to the Department of Health and it is likely the requirement to perform reversibility testing will be removed from the framework soon.
In the meantime, GPs who follow the NICE advice on reversibility testing will fear missing out on quality payments as a result. I would endorse the approach of making a provisional diagnosis in line with the NICE recommendations and performing reversibility testing after a month of treatment. GPs will fulfil the quality indicator – and this approach has the added attraction of finding out if the patient has found the treatment helpful.
Reversibility testing is not the only controversial area in the quality framework – it also defines COPD as an FEV1 less than 70 per cent predicted. Every other guideline in the world uses a diagnostic threshold of FEV1 less than 80 per cent predicted. What are GPs supposed to do with the fairly large group of mild patients between 70-80 per cent who still need smoking advice and perhaps other forms of therapy – ignore them as they may spoil our figures? The answer is a resounding No as early diagnosis and treatment may prevent the development of significant clinical disease.
The Q&O framework is an important first step in encouraging GPs to think about COPD and make the correct diagnosis. But it already needs updating to reflect the latest evidence on reversibility testing, and I believe the FEV1 diagnostic criterion must be changed to bring it in line with current thinking and avoid confusion.
David Bellamy is a GP in Bournemouth – he was the GP representative on the NICE COPD guidelines group and serves on the BTS COPD consortium